Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsul...
FDA Recall #D-0161-2023 — Class III — November 9, 2022
Product Description
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Reason for Recall
Failed Impurity/Degradation Specifications
Recalling Firm
Lannett Company Inc. — Seymour, IN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
20,040 bottles
Distribution
Nationwide USA
Code Information
Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated